- Physicians Office Resource

Fetal Spiral Electrode For Corometrics
Vital Signs - 7000AAO

Device Description

A sterile electrical conductor designed to transmit electric signals from the foetal scalp to an intrapartum monitor. The device is a spiralled (either single- or double-helix) metallic electrode with a sharp tip that is directly inserted into the foetal scalp with a screwing action; and an adaptor cable that may include a transducer. The electrode penetrates into the scalp up to 2.5 mm (0.1 inch); it is usually inserted with a dedicated applicator that may be included. The electrode is typically used to monitor a foetal physiologic signal (e.g., heart rate) during labour (intrapartum) after rupture of the amniotic sac. This is a single-use device.

Environmental Conditions

Storage Environment Temperature - Degrees Fahrenheit

100.00
41.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: HGP

Device Name: Electrode, Circular (Spiral), Scalp And Applicator

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OB

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 884.2675

Third Party Flag: Y

Medical Specialty: OB

Device Identifiers

Device Id: 50885403248960

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10885403248962

Package Quantity: 50

Package Discontinue Date: 3/31/2022 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Case

Device Id: 10885403248962

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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